NCT02734277

Type 1 Diabetes Extension Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 111 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 8 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D). This observational study will: * follow participants to determine how long they continue to produce insulin, and * will also assess how changes in the immune system over time relate to the ability to produce insulin. This information could help design better therapies for type 1 diabetes in the future.

Detailed description

Depending upon a participant's level of insulin production, participation may be as short as one return visit or a maximum of five years. Evaluation visits will include: * Overall health assessments * Blood and urine collections * Mixed meal tolerance test (MMTTs) for certain participants, per protocol.

Conditions

• Type 1 Diabetes Mellitus
• T1DM
• T1D

Timeline

• Start date: 2016-08-18
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2016-04-12
• Last updated: 2026-03-10

Locations

12 sites across 1 country: United States